The primary purpose of this study is to assess whether at least one dose of LY2216684 (12 mg or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of patients with major depressive disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI), during an 11-week, double-blind, acute adjunctive treatment phase.

A Randomized, Placebo-Controlled, Double-Blind Study of LY2216684 Fixed-Dose 12 mg and 18 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment

Percentage of patients achieving a MADRS total score of less than or equal 10 at week 11 [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Percentage of patients achieving a MADRS total score of less than or equal 10 at 2 consecutive measurements including the patient's last measurement [ Time Frame: Through 11 weeks ] [ Designated as safety issue: No ]

Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 condition other than major depression within 1 year of screening

Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias)

Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder

Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine.

Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol

Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, urinary hesitation or retention

Use of excluded concomitant or psychotropic medication other than SSRI

Have initiated or discontinued hormone therapy within the previous 3 months of prior to enrollment

Have treatment resistant depression

Have a lifetime history of vagal nerve stimulation, transcranial magnetic stimulation, or psychosurgery

Have received electroconvulsive therapy in the last year

Enrollment in a clinical study for an investigational drug

Serious or unstable medical condition

History of seizure disorders

Have initiated psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 12 weeks prior to enrollment or any time during the study. No change in intensity of psychotherapy within the last 6 weeks prior to enrollment or at any time during the study.

Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173601